Opening assembly for bags housing containers for pharmaceutical use

ABSTRACT

An opening assembly for bags housing containers for pharmaceutical use, including at least one clamping mechanism for clamping a portion of said bag spaced apart with respect to an end flap of the bag, said clamping mechanism arranged so as to clamp together sections of opposing sheets of said bag, and at least one cutting element for the trimming and the separation of said end flap with respect to said sections of said opposing sheets of said bag mutually clamped together by said clamping mechanism.

The present invention relates to an opening assembly for bags housingcontainers for pharmaceutical use.

The bag of specific interest is intended for containment and segregationwith respect to the outside environment of containers such as vials,bottles, syringes, carpules and the like.

These containers undergo washing and sterilization treatments to ensurethat there is no residue inside them (not even dust particles and thelike) and to remove any contaminants from their surfaces.

These containers are also normally collected in a nest, which alsoundergoes similar washing and sterilization treatments.

The nest is, in turn, placed inside a sterile tub with a protective filmon top which has the purpose of preventing entrance into the containers(which have an upper opening open towards the outside) of dust or otherparticles.

The upper edges of the tub (containing protective film, nest andcontainers) are permanently joined to a sealing film in order tocompletely isolate the inside of the tub from the outside.

The sealed tub is placed within a bag (generally made of polymericmaterial) which constitutes a second protective barrier (since theoutside of the tub and the sealing film must in any case be sterile).

In this way it is possible to transport the containers so packaged withthe guarantee that they will not be subject to involuntarycontamination.

Once at the factory where the containers will be filled with specificsubstances of various types, they will need to be handled in order to betransported first to the station at which the bag will be opened, andthen to the station where the opening film will be removed and finallythe filling station for each single container.

These operations will be performed in environments that present aspecific particle contamination class (filling operations will beperformed in the environment with a lower risk of contamination).

Environments and products are identified by contamination classesdefined according to ISO14644/1: the highest contamination class(therefore relating to the environment in which the smallest particlesize corresponds at least to that defined as “ISO Class 5” (thus, itcould also be an ISO Class 4, 3, 2, 1). Bag opening operations should becarried out in an environment with a lower risk of contaminationcompared to the one in which the bags are transported, while theprotective film may be removed from the tub only in the environment withthe least risk of contamination (i.e., in an environment with ISOcontamination class of 5 or lower), imposing additional constraints onthe step when removal of the protective film is carried out. It isspecified that the atmosphere inside the bag will also present a verylow contamination class (such as, an ISO Class less than or equal to 5).

In any event, bag opening operations are such as to give rise to a riskof contamination (during the cutting step, particles may in fact detachand enter inside the bag, coming into contact with the protective filmor the outside of the tub). The presence of particles on the protectivefilm and/or the outer surface of the tub is particularly risky becauseremoval of the film generally occurs when the tub is already in theenvironment with the highest contamination class (i.e., ISO 5 Class orlower, thus, with the least presence of contaminants) and could causethe diffusion of such particles (deposited on the film and/or tub) inthat environment.

DE 10 2011 080289 discloses a device for opening a bag according to theprior art.

The main aim of the present invention is to solve the problems outlinedabove, by proposing an opening assembly for bags housing containers forpharmaceutical use capable of cutting the outer bag while preventingparticles, in suspension and/or generated during the cutting step, fromentering inside the bag.

Within the scope of this aim, an object of the invention is to proposean opening assembly for bags housing containers for pharmaceutical usethat ensures isolation of the bag's content with respect to the outsideenvironment even after opening the bag.

Another object of the invention is to propose an opening assembly forpackaging of containers for pharmaceutical use capable of guaranteeingsterility of the containers transported in the nest present inside thetub, sealed by a protective film, and segregated inside the bag.

It is a further object of this invention to provide an opening assemblyfor bags housing containers for pharmaceutical use at a low cost andrelatively simple, practical implementation and safe application.

This aim and these objects are achieved by an opening assembly for bagshousing containers for pharmaceutical use in accordance with claim 1.Further characteristics and advantages of the invention will becomeapparent from the description of a preferred, but not exclusive,embodiment of the opening assembly for bags housing containers accordingto the invention, illustrated by way of a non-limiting example, in theaccompanying drawings, in which:

FIG. 1 shows, in a schematic axonometric view, a portion of an openingassembly for bags housing containers for pharmaceutical use according tothe invention;

FIG. 2 shows, in a schematic side view, the opening assembly for bagshousing containers for pharmaceutical use according to the invention;With particular reference to the aforementioned figures, it is generallyindicated with 1 an opening assembly for bags B housing containers A forpharmaceutical use.

The bag B is generally hermetically sealed and preferably made ofpolymeric material.

The assembly 1 comprises at least one clamping mechanism 2 to clamp aportion C of the bag B spaced apart (inwardly) with respect to an endflap D of the bag.

The clamping mechanism 2 is arranged so as to clamp together sections ofopposing sheets E, F of the bag B.

The assembly 1 further comprises at least one cutting element 2 a forthe trimming of the end flap D with respect to the portion C defined bythe sections of opposing sheets E, F of the bag B mutually clampedtogether by the clamping mechanism 2.

In this way, it is possible to ensure the clamping of sheets E and F (inparticular the portion C on which the clamping mechanism 2 acts) such asto completely segregate and seal the inside of the bag B with respect tothe outside environment.

After this step is performed (which ensures that no contamination of thecontents of the bag B can occur), the end flap D of the bag B (thus, theopening of the bag B) can then be removed. The transfer to subsequentoperating stations where it may be necessary to access the contents ofthe bag B will occur while the sections of opposing sheets E and F(portion C) are clamped together sealed by the clamping mechanism 2 andthus under such conditions as to prevent contamination of the contentsof the bag B. However, during this transfer, the bag B is in factalready opened (because it is without the end flap D) and thussubsequent access to its contents will not require any operation capableof generating contaminants and/or particles (which may in fact detachduring the cutting step) thereby greatly improving the sterility andcleanliness of containers A transported inside the bag B.

In accordance with the present invention, the opening assembly furthercomprises gripping mechanisms 14 equipped with at least one clamping jaw15 for gripping the end flap D of the bag B when the bag B hangs fromthe at least one said jaw 15 of the gripping mechanism 14.

This arrangement is extremely advantageous as it ensures that noundesirable particle buildup can occur on any of the outer surfaces ofthe bag B: in the traditional type handling units, the bags B lie onto aconveyor belt. The surface of the conveyor belt faces a laminar airflow, but it is not possible to exclude the deposit of particles on thesame.

In any case, when the bags B lie on the conveyor belt's surface, theside of the bag B in contact with the conveyor belt is not exposed tothe flow and therefore any accumulations of particles (present on theside of the bag B or on the conveyor belt) will not be affected by theflow which will thus not remove them.

Advantageously, the cutting element 2 a is designed to separate the endflap D and is arranged between the gripping mechanisms 14 and theclamping mechanism 2.

Preferably, these gripping mechanisms 14 are associated with a transportdevice 5.

The transport device 5 in the illustrated example comprises a proximalsection 10 arranged in a first zone 9 and a distal section 12 arrangedin a second zone 11, wherein the first zone 9 has a higher contaminationclass and a higher ambient pressure than the second zone.

Said transport device 5 may be a closed loop design and driven by anautomatic motor drive unit connected to a control and managementprocessor.

In accordance with a preferred embodiment of the present invention, theclamping mechanism 2 is integral with a moveable terminal end 3 of amanipulator 4.

In this way, after clamping the portion C with the clamping mechanism 2and removing the end flap D with the cutting element 2 a, it is possibleto remove the bag B (and its contents isolated from the outsideenvironment) from the transport device 5 through the manipulator 4,maintaining the sections of opposing sheets E, F mutually clampedtogether by means of the clamping mechanism 2, and deliver them to apossible downstream operating station.

It is considered useful to specify that the manipulator 4 canadvantageously move between at least two end configurations.

A first configuration whereby the bag B is removed from the transportdevice 5 for the clamping of said opposing sheets E, F with the clampingmechanism 2; and a second alignment configuration whereby the bag B isbrought in proximity to an opening 6 defined on a separation wall 7separating the first zone 9 from a compartment 8 with a highercontamination class and higher ambient pressure compared to the firstzone 9.

By way of example, it is specified that inside the compartment 8, an ISOcontamination class of “5” or lower, more “safe” compared to the one inthe first zone 9, could be established.

With particular reference to an embodiment capable of meeting thestringent regulatory requirements in force concerning the packaging ofdrugs and even define improved safety standards in connection with thesame, the first zone 9 within which the manipulator 4 operates and inwhich the proximal section 10 of the transport device 5 is located, hasa higher contamination class and a higher ambient pressure compared tothe second zone 11 in which the distal section 12 of the transportdevice 5 is located. In practice, an operating condition will occurwhereby the transport of packaging A will be carried out in ambientconditions with a less stringent contamination class (i.e, ISO Class 6or ISO Class 7), the cutting of the end flap D and thus the opening ofthe bag B will occur in ambient conditions with an intermediatecontamination class (according to the previous example, in ISO Class 6or ISO Class 6+ or ISO Class 5 respectively), while the extraction ofthe contents of the bag B will only occur in the compartment 8 in whichthere is a higher contamination class (according to the previousexample, ISO Class 5).

According to a particularly efficient and easily programmable version,the manipulator 4 can be an anthropomorphic-type robot.

In the first zone 9, there is preferably arranged at least one dispenserof a gas flow intended to flow over the proximal section 10 of thetransport device 5, the bag B transported along the end section 10 andthe manipulator 4.

Such gas flow will provide the necessary overpressure in the first zone9, with respect to the second zone 11 in which the distal section 12 ofthe transport device 5 is located so as to prevent access to the firstzone 9 of particles and/or contaminants present in suspension in the airin the second zone 11.

It is specified that, preferably, the gas flow present in the first zone9 will be of the laminar type.

With reference to an embodiment that is simple to implement, it shouldbe noted that the gas relating to such flow may be air (other types ofgas such as inert gas, nitrogen and the like are not excluded).

The transport device 5 thus adopted allows all surfaces of each bag B tobe invested by the gas, favoring the detachment of any particlesaccumulated thereupon, while hindering the deposit of any otherparticles present in suspension in the air of the particular environmentin question.

The operation of the present invention is precisely outlined in thesteps listed below.

In a first step, it is necessary to have a portion C of the bag B,spaced apart (inwardly) relative to an end flap D, in alignment with aclamping mechanism 2.

Subsequently, in a second step, it will be necessary to clamp, with theclamping mechanism 2, sections of opposing sheets E, F of the bag B,that is, the portion C, isolating the contents of the part of bag B thatis downstream with respect to the clamping mechanism 2.

A final step of the process involves trimming by means of a cuttingelement 2 a the end flap D with respect to the portion C correspondingto the sections of opposing sheets E, F of the bag B mutually clampedtogether by the clamping mechanism 2.

Preferably, the process involves aligning the portion C of bag B to theclamping mechanism 2, keeping it sealed by isolating the contents of thebag B from the outside environment, at a subsequent operating station,so that the containers A placed inside the bag B remain isolated fromthe outside environment even after the trimming.

Advantageously, the present invention solves the problems outlinedabove, by proposing an opening assembly 1 for bags housing containersfor pharmaceutical use, preventing particles, in suspension and/orgenerated during the cutting step, from entering inside the bag B.

Effectively, the opening assembly 1 according to the inventionguarantees the isolation of the contents of the bag B from the outsideenvironment even after cutting the bag B.

Appropriately, the opening assembly 1 according to the invention iscapable of guaranteeing the sterility of the containers transported inthe nest inside the tub, sealed by a protective film, and segregatedinside the bag B. Beneficially, the opening assembly 1 according to theinvention is relatively simple and practical to implement, and alsoentails contained costs: these features make the unit 1 an innovativeand safe application.

The invention, thus conceived, is susceptible to numerous modificationsand variants all falling within the scope of the inventive concept;moreover, all of the details may be replaced by other technicallyequivalent elements. In the sample embodiments illustrated, individualfeatures, described in relation to specific examples, are in factinterchangeable with other different features, existing in otherembodiments.

In practice, the materials used, as well as their sizes, may be of anykind according to the requirements and the state of the art.

1. An opening assembly for bags housing containers for pharmaceuticaluse, comprising: at least one clamping mechanism for clamping a portionof said bag and at least one cutting element, wherein said clampingmechanism is arranged to clamp together sections of opposing sheets ofsaid bag which are spaced apart with respect to an end flap of the bagand in that said at least one cutting element is arranged and configuredfor the trimming and the separation of said end flap protruding withrespect to said sections of said opposing sheets of said bag mutuallyclamped together by said clamping mechanism.
 2. The opening assemblyaccording to claim 1, comprising gripping mechanisms equipped with atleast one clamping jaw for gripping said end flap of the bag, said baghanging from the at least one jaw of the gripping mechanism.
 3. Theopening assembly according to claim 2, wherein said gripping mechanismsare associated to a transport device.
 4. The opening assembly accordingto claim 3, wherein said transport device comprises a proximal sectionarranged in a first zone and a distal section arranged in a second zone,wherein the first zone has a higher contamination class and a higherambient pressure than the second zone.
 5. The opening assembly accordingto claim 3, wherein said transport device has a closed loopconfiguration and is driven by an automatic drive unit connected to acontrol and management processor.
 6. The opening assembly according toclaim 2, wherein said cutting element is arranged between said grippingmechanisms and said clamping mechanism, when the end flap is separatedfrom said sections of opposing sheets clamped by the clamping mechanism.7. The opening assembly according to claim 1, wherein said clampingmechanism is integral with a movable terminal end of a manipulator. 8.The opening assembly according to claim 7, wherein said manipulator isan anthropomorphic-type robot.
 9. The opening assembly according toclaim 7, wherein said manipulator is movable between at least two endconfigurations, a first configuration wherein the bag is removed fromsaid transport device for the clamping of said opposing sheets with saidclamping mechanism, and a second configuration wherein the bag isbrought in proximity to an opening defined on a separation wallseparating said first zone from a compartment with a highercontamination class and higher ambient pressure compared to the firstzone.
 10. The opening assembly, according to claim 9, wherein in saidfirst zone, there is arranged at least one dispenser of a gas flowintended to flow over the proximal section of said transport device,said bag transported along said end section and said manipulator locatedin the first zone.
 11. The opening assembly according to claim 10,wherein said gas flow is of the laminar type.
 12. A method for openingbags housing containers for pharmaceutical use, comprising the steps of:arranging a portion of said bag spaced apart with respect to an end flap(D) in alignment with a clamping mechanism (2); clamping togethersections of opposing sheets of said bag with said clamping mechanism;trimming and separating, by means of a cutting element, said end flapwith respect to said sections of said opposing sheets of said bagmutually clamped together by said clamping mechanism.
 13. The methodaccording to claim 12, further comprising the step of aligning theportion of bag clamped by said clamping mechanism at a subsequentoperating station.
 14. The method according to claim 12, wherein theclamping of the bag with the clamping mechanism keeps said sections ofopposing sheets clamped together, so that the containers placed insideof the bag remain isolated from the outside environment even aftertrimming.